Radically Open Dialectical Behaviour Therapy for Anorexia Nervosa
Evaluating the Efficacy of Radically Open Dialectical Behaviour Therapy (RO-DBT) in Patients With Anorexia Nervosa: a Randomized Controlled Clinical Trial
NA · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · NCT06050421
This study is testing whether adding a new therapy called Radically Open Dialectical Behaviour Therapy to standard treatment can help people with anorexia nervosa improve their mental health and reduce the chances of relapse.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (other) |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06050421 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of Radically Open Dialectical Behaviour Therapy (RO-DBT) in patients with anorexia nervosa, focusing on psychosocial adjustment and relapse rates. Participants will be randomly assigned to receive either treatment as usual (TAU) or TAU plus RO-DBT. The study aims to address the limitations of traditional therapies that primarily focus on weight restoration without improving psychosocial outcomes. Additionally, it will explore neuroimaging changes to understand the biological mechanisms underlying RO-DBT's effects.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 to 65 with a diagnosis of anorexia nervosa who have undergone weight restoration treatment.
Not a fit: Patients with severe mental illnesses, borderline personality disorder, or those currently undergoing standardized psychotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could lead to improved social adjustment and reduced relapse rates in patients with anorexia nervosa.
How similar studies have performed: This approach is novel, as no previous clinical trials have demonstrated the efficacy of RO-DBT in treating anorexia nervosa.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * female patients * aged between 18 to 65 years old, * having a diagnosis of AN (DSM 5 criteria), * having had weigh restoration treatment (normal BMI considered \>19 kg/m2) * having an overcontrol personality style assessed with the styles of coping Word-Pair Checklist scale (ASC-WP) Exclusion Criteria: * diagnosis of severe mental illness (schizophrenia or other psychosis, bipolar disorder, major depressive disorder, substance use disorder) * diagnosis of borderline personality disorder (BPD) or positive result in McLean Screening Instrument for BPD * mental retardation * being under standardized psychotherapy at the baseline * being illiterate or not able to understand Spanish language, * being left-handed * being pregnant for MRI requirements.
Where this trial is running
Barcelona
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (RECRUITING)
Study contacts
- Principal investigator: Cristina Carmona — Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Study coordinator: Cristina Carmona, Doctor
- Email: ccarmonaf@santpau.cat
- Phone: 0034650003427
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anorexia Nervosa, Anorexia Nervosa in Remission, Anorexia Nervosa Restricting Type, anorexia nervosa, RODBT